RDS Workshop - How to Become a Fundable Researcher My NIHR application journeys Dr Stacy Clemes School of Sport, Exercise and Health Sciences Loughborough University

My journeys… Stand Out in Class: Restructuring the classroom environment to reduce sedentary behaviour - a pilot cluster randomised controlled trial Submitted to the NIHR’s Public Health Research (PHR) Programme – 1st April, 2015 PHR researcher-led scheme

My journeys… A cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of a Structured Health Intervention For Truckers (The SHIFT Study) Submitted to the NIHR’s Public Health Research (PHR) Programme – 6th April, 2016 PHR Obesity Themed call

Why the NIHR PHR programme?

My journey – Stand Out in Class Work commenced on the Stand Out in Class Study in August 2013 Initial funding application to the Wellcome Trust’s sustaining Health funding scheme for pilot studies Unsuccessful – September 2013

Feasibility study September – October 2013, building relations with an industrial partner who manufactures sit-stand desks January 2014 – the start of our unfunded feasibility study in Bradford

Feasibility study The feasibility of incorporating sit-stand desks in a primary school classroom over 1 school term Bradford chosen as the study setting due to its high levels of deprivation and ethnic diversity

Feasibility study Feasibility study completed – July 2014 Key findings: Uptake into the study was high (54/55 children, 98%) Compliance to the primary outcome (activPAL inclinometer) was low (30/54 children provided valid data, 56%) Classroom sitting reduced by 10% (52 mins/day) The school found the intervention beneficial and asked for more desks!

A comparative feasibility study

A comparative feasibility study In the Australian study, classroom sitting reduced by 9% (44 mins/day)

Grant preparation – Stand Out in Class Findings from both feasibility studies informed the grant application Grant preparation commenced July 2014 The two feasibility studies were written up as one paper (accepted December, 2014) Original intended grant submission – December 2014 Submission postponed to the April 2015 deadline

Grant preparation considerations The study team: Based on feedback from earlier applications (Wellcome Trust and NIHR application), the proposed outcomes were diverse and multidisciplinary Two team members had successfully secured NIHR PHR funding previously Health economics highly valued by NIHR Caution: large teams are expensive and need justifying!

Grant preparation considerations The study team: Engagement with a clinical trials unit (CTU) Caution: allow time to engage with a CTU and determine the level of support required and costs

Grant preparation considerations PPI: We conducted extensive PPI to inform our application, including interviews/focus groups with teachers, Year 5 children, parents, and school management Teachers provided valuable suggestions on timelines for data collection Parents provided valuable information on how we can increase compliance to the primary outcome

Grant preparation considerations Letters of support: Engagement with Industrial partners who will provide sit-stand desks for the intervention (given NIHR do not fund intervention costs) Engagement with schools willing to participate in the study Engagement with relevant stakeholders Confirmation of support from international collaborators

Grant preparation considerations Preparation of the written application: Create a word document containing all sub-headings from the online form, make a note of each sections character limit Cross-check the draft text against the specific programme board’s guidance notes

Grant preparation considerations Preparation of the written application: Where possible, take a look at previous successful applications Allow time for colleagues to input and review the text Seek external peer review – RDS feedback was invaluable to us!

Grant preparation considerations Application start date and timescales: Are the proposed timescales realistic? Discuss any potential constraints regarding timescales with NIHR staff Caution: do not be too ambitious with your proposed start date

Post April 2015 (Stand Out in Class) 1st April: Application submitted 30th June: Outcome of board meeting received - invited to submit a full proposal for consideration at October meeting 25th August: deadline for full proposal 10th September: 6 sets of reviewer comments received, 2 week response time 24th September: Response to reviewer comments submitted

Post April 2015 (Stand Out in Class) 4th November: informed application was going to be held over to the February board meeting

Post April 2015 (Stand Out in Class) 4th November: informed application was going to be held over to the February board meeting 22nd December: informed application had been provisionally recommended for funding, 5 weeks to respond to the board’s comments 29th January, 2016: proposal updated and resubmitted

Post April 2015 (Stand Out in Class) 9th June, 2016: Our response to the Board’s comments reviewed, requested to respond to two further minor comments 15th June, 2016: Our response to these comments submitted 18th August, 2016: Final sign-off and funding confirmed 1st October, 2016: Official project start date (contracts signed 31st Oct, 2016)

My journey – SHIFT Work commenced on the SHIFT study in October 2013 This application was informed by the work of a PhD student and a Knowledge Transfer Partnership agreement between Loughborough University and a local logistics company Preparatory work included: A surveillance study looking at health behaviours of HGV drivers Qualitative work with HGV drivers Piloting of a 3 month intervention (pre-post design)

Grant preparation – SHIFT September/October 2015 – discussions with research team about applying for funds to continue this research, search begins for new logistic industry partners December 2015 – NIHR announce ‘Obesity Themed Call’ January 2016 – Grant writing begins 6th April 2016: Outline application submitted 27th June 2016: Outcome of board meeting received - invited to submit a full proposal for consideration at October meeting

Grant preparation – SHIFT 19th August 2016: deadline for full proposal 6th September 2016: 4 sets of reviewer comments received, 2 week response time 19th September 2016: Response to reviewer comments submitted 25th November 2016: informed application had been provisionally recommended for funding, 5 weeks to respond to the board’s comments 6th January, 2017: proposal updated and resubmitted

Grant preparation – SHIFT 27th January 2017: Revised application approved, funding agreed 15th February 2017: List of tasks provided required before release of funds (including ethical approval [1st April], study timeline, trial steering committee names, trial registration [1st May]) 22nd February 2017: Contracts sent to university Proposed project start date – 1st June 2017

Getting projects up and running Work needed before funding begins: Staff recruitment (job adverts) Ethical approval Trial registration Nomination of project oversight groups Confirmation of trial timelines (liaise with external partners) Development of trial protocol Creation of Case Report Forms (CRFs) in collaboration with CTU Confirmation of covering costs of intervention PI’s time management, support from employer?

Inspiring Winners Since 1909 Thank you! Stacy Clemes S.A.Clemes@lboro.ac.uk @StacyClemes Inspiring Winners Since 1909